Cleaning process validation
Cleaning Process Validation
Radioactive Labeling (RNM) and direct Protein Detection (OPA, BCA etc.)
Cleaning process test provided by SMP GmbH of Germany
RNM法
放射性核種法(RNM)は、直接目視できない領域のある医療機器の洗浄プロセスの評価とバリデーションに最適な方法です。
OPA法
ISO15883に準拠したたんぱく質定量測定方法の1つです。
BCA法
ISO15883に準拠したたんぱく質定量測定方法の1つです。
定量ヘモグロビン法
SMP社ではたんぱく質とともに残留ヘモグロビンも定量測定します。
RNM method (radionuclide method)
Medical devices with various complex structures are currently being developed, and it may not be possible to visually confirm the effectiveness of cleaning without disassembling or destroying the device. In addition, visual inspection provides only a qualitative assessment of the cleanliness of the device and misses biologically important protein residues such as blood fibrin that are invisible to the naked eye. The Radionuclide Method (RNM) is the best method for evaluating and validating the cleaning process of medical devices with areas that are not directly visible. The use of radiolabels on the test soil enables reliable non-destructive analysis of the amount and location of radioactivity remaining after the cleaning process.